The present invention relates generally to medical prostheses, particularly to urological prostheses and methods of implantation for improved erectile function, and particularly to penile implants comprising an elastic mantle, internal elements and filling material for implanting into the corpora cavernosa, without requiring a surgical operation, and an implantation method therefore.
Male impotence is wide spread worldwide. Some data indicate that more than thirty million people between the ages of twenty-five years and sixty years suffer from impotence in the United States alone. A number of various methods have been used to treat impotence, including pharmaceutical medicines such as Viagra or Apomorphine, natural remedies, use of external apparatus and devices to create vacuum in the penile area, implantation of prosthesis in the penile cavity called the corpora cavemosa to create an artificial erection, surgical implantation of penile prosthesis filled with solution, or implantation of a drug storage unit remote from penile tissue, but connected by a thin tubing for delivery of vasodilating drugs such as prostaglandin E1, papaverine, or the like.
Several prior art patents have described penile prostheses comprising of plastic pliable elements with constant rigidity, for example, the Semirigid and Malleable Rod Penile Prostheses, located coaxially inside a silicon stem devices such as the Jonas Prosthesis, Flexirod, or the AMS-600. U.S. Pat. No. 3,987,789; U.S. Pat. No. 4,392,562; U.S. Pat. No. 4,066,073; U.S. Pat. No. 4,594,998. Disadvantageously, these types of devices are continuously rigid and cause discomfort for the patient.
Other types of penile prostheses include surgically positioned pumps for creating high pressure of liquid in the elastic silicon mantle, for example, U.S. Pat. No. 5,658,329; U.S. Pat. No. 5,803,897; U.S. Pat. No. 4,566,446; U.S. Pat. No. 4,782,826; U.S. Pat. No. 4,224,934; U.S. Pat. No. 4,235,227; U.S. Pat. No. 4,201,202; U.S. Pat. No. 4,342,308; U.S. Pat. No. 4,009,711; U.S. Pat. No. 3,853,122; U.S. Pat. No. 3,954,102; U.S. Pat. No. 5,062,417; U.S. Pat. No. 5,230,694; U.S. Pat. No. 5,167,611 or U.S. Pat. No. 4,267,829. Generally, the inflatable chambers of these prostheses are situated in the corpora cavernosa, the liquid reservoir is implanted in the inguinal area, and the pump is situated in the scrotal sac. Unfortunately, implanting these devices almost always requires implanting several components into the patient""s body, for example, the reservoir with liquid, pump, several valves, connecting pipes, and the like, in addition to those components implanted directly into the penis. Therefore, the implantation of these elements requires complicated, surgical, lengthy and costly procedures to be performed. Moreover, these devices themselves are complex and expensive.
The prior art also teaches devices which use an external source of electricity and a source of alternating magnetic field changing with the frequency of 50 to 1000 Hz which influence the internal element located in the penis. This element senses the magnetic field and causes liquid in the inner reservoir to move from the reservoir into the elastic mantles located in the corpora cavernosa, and causes the penis to erect. U.S. Pat. No. 4,584,994; U.S. Pat. No. 5,427,605; U.S. Pat. No. 4,491,461 and U.S. Pat. No. 5,803,897 describes a permanent magnet which makes seesaw movements under the influence of this field. This in turn causes liquid from the reservoir to pump into the elastic mantles, thus serving as an internal element sensing alternating magnetic field of the external source.
U.S. Pat. No. 5,230,694 describes penile prostheses not containing pumps and reservoirs with a liquid, but is provided with an internal element with alternating rigidity placed in an elastic mantle which is closed by plugs at its side. The element is made in the form of a spring having coils which can be moved manually from one end of the prosthesis which is fixed to the patient""s body, to its other end, thereby causing the penis to erect. The position of the spring""s coils is fixed by the group of permanent magnets. These magnets are in the form of stems which are parallel to one another and are homopolarly turned to each other. The magnets"" ends touching the moving spring coils are equipped with conic bulges which couple with the spring coils. Therefore, the magnets hold the spring coils by their bulges by repelling each other. However, such a construction is not sufficiently reliable. This is because it is necessary to squeeze the magnets in order to empty the erecting chambers. And since the magnets are located in the spring, it is necessary to squeeze the spring in the direction perpendicular to its longitudinal axis. The spring is highly rigid and one has to squeeze the penis strongly from the outside using one""s fingers, which is a painful procedure. Moreover, the implantation of the prosthesis requires similar surgical procedures as described above for currently available penile prostheses.
Even worse, the complicated surgery may result in damage of erectile tissues and post-operative complications. Moreover, many of conventional mechanical prostheses have somewhat frequent mechanical malfunction and may require additional surgery to replace the prosthesis. Nevertheless, about twenty thousand such surgical operations are performed each year in the United States alone.
The drawbacks of the current methods of implantation and above devices are that, independently of the type of prosthesis and components used, these units are implanted into the penis by means of conventional surgical operation, by making a surgical cut in the area of the penile skin, corpora cavernosa or the scrotum for implanting the prosthesis. Such surgical operations are complex, expensive and inconvenient.
It is therefore an object of the invention to provide a non-surgical, non-intrusive penile erection device, and which reduces the pain associated with mechanical malfunction of devices.
It is also an object of the invention to provide an implantation procedure for penile prosthesis, which procedures requires no surgery, and can be carried out in an outpatient clinic.
The present invention overcomes the problems associated with previous devices and implantation methods by preferably implanting a penile prosthesis without requiring a complicated surgical procedure thereby making the procedure cost-effective and possible in an outpatient setting.
The penile prosthesis device of the present invention includes an elastic mantle in the shape of a balloon or tube, the mantle is plugged at each end and is filled with a biocompatible liquid. The prosthesis device is inserted into the cavernous cavity by means of a trocar, and requires no surgical procedure.
An additional embodiment of the invention includes a prosthesis unit having alternating rigidity and a catch for locking its position using a plurality of permanent magnets. The prosthetic device unit having the alternating rigidity comprises a thin wire, preferably made of steel, and a plurality of short discrete cylindrical elements. Each of the cylindrical elements further includes an axis hole through which passes the above-mentioned wire. The elements are coupled to each other end to end.
In another embodiment of the invention, every discrete element of the unit with alternating rigidity is made in the form of a cylinder with the alternating cut done in such a way that the outer diameter of the front of the minimal cut corresponds to the inner diameter of the front of the maximal cut.
In yet another embodiment, the discrete elements of the unit with alternating rigidity are made of ferromagnetic and non-ferromagnetic material and are located along the wire in the form of interchanging rows. One of the ends of the wire is attached to the plug at the first end of the elastic mantle. A part of the rigid pipe attached on the inner surface of the elastic mantle near its second end, is injected into the prosthesis.
In a different embodiment, the first magnet of the catch of the unit""s position with alternating rigidity is attached by one of its ends or poles to the inside part of the rigid pipe. A second magnet of the catch of the unit""s position with alternating rigidity and is attached by one of its ends or poles to the inside part of the rigid pipe, coaxially with the first fixed magnet, and is turned to it by its opposite end, the second end or pole of which is connected with the free end of the wire. The prosthesis is equipped with an external driver interacting with the internal catch of the unit. The external driver is made in the form of a third permanent magnet which interacts with the internal movable magnet by means of the magnetic field. The third magnet is in the form of a heavy walled pipe and an inner diameter corresponding to the size of the penis. The external driver is equipped with an element for uncoupling the third permanent magnet and the internal movable magnet.
The uncoupling element is made in the form of a ferromagnetic pipe which is inserted into the inner hole of the third magnet, and is able to move on the axis while the conjugated surfaces of the ferromagnetic pipe and the magnet are covered with a material such as Teflon, that provides a suitable drag coefficient. The uncoupling element further has the catch of position as described in detail in FIG. 6 for an uncoupling element used for two opening halves with a faster. Additionally, the elastic mantle may be equipped with an external arm made of thin non-elastic net attached at its ends to the plugs. The elastic mantle may also have a syringe activated checkvalve attached in one of the pipes. These particular characteristics in the construction of the penile prosthesis in the present invention, enable it to work reliably since the position of the unit influences the catch by means of the magnetic field of the external magnet, without deforming the penis and the internal elements of the prosthesis.
Additionally, the penile prosthesis unit with the alternating rigidity and its catch enable the prosthesis to reduce to its original state or in the non-erectile state. In this state, the prosthesis can be inserted with ease into the corpora cavernosa by a trocar like larger caliber needle, thus avoiding the need for surgical procedures involving incisions, as is the case now, when implanting a penile prosthesis.
An additional aspect of the present invention is the method of implantation of the semirigid, malleable, rod penile prosthesis and the like. For example, by implanting into the penis separately, the elastic mantle with inside elements and the filling material, using a needle-shaped catheter directly in to the penile corpora cavernosa, without making a surgical incision. Optionally, the elastic mantle may be partially pre-filled, or the filling material may be inserted into the elastic mantle already placed in the corpora cavemosa, through a needle catheter and valve. The filling material may include standard physiological solution, biocompatible elastomer, silicone, oil, or other material in liquid form. This material may cure or harden after filling. Before insertion of the elastic mantle into the corpora cavernosa the implantation method may include a step of expanding the cavity by using a high-pressure balloon, similar to angioplasty balloons.
A further benefit of the implantation method of the present invention is the minimum erectile tissue disruption created by insertion of the unfilled or partially filled elastic mantle directly into the corpora cavemosa of the penis. The elastic mantle may be filled with small diameter elements, such as malleable rods or other elements of similar diameter, through a needle-catheter approximately 2.5 to 6 mm in diameter, preferably 4 to 4.5 mm in diameter, without making a surgical incision in the penis.
After its insertion, the mantle is filled with a sufficient amount of a liquid which may or may not be self-curing. Filling the mantle is done through a valve, either by a needle catheter or by a smaller caliber needle. If a self-curing biocompatible elastomer, for example, silicone or the like, is inserted, its curing time after its injection into the elastic mantle is predetermined. The creation of the intracorporeal cavity for the elastic mantle by using a longitudinal high-pressure balloon allows the elastic mantle to reach a smooth cylindrical form upon filling with the biocompatible material.